a study of the safety and pharmacokinetics of sar245409 tablets in patients with solid tumors or lymphoma

Conditions: Neoplasm Malignant

Summary: primary objective: - to evaluate the safety and tolerability of sar245409 tablets administered once or twice a day in patients with solid tumors or lymphoma. secondary objectives: * to evaluate blood levels of sar245409 after administration of sar245409 tablets once or twice a day in patients with solid tumors or lymphoma. * to evaluate the effect of food on blood levels of sar245409 after administration of sar245409 tablets in patients with solid tumors or lymphoma. * to evaluate the effect of sar245409 on the body after administration of sar245409 tablets once or twice a day in patients with solid tumors or lymphoma. * to obtain information on how sar245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire. * to explore the antitumor activity of sar245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.

the total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last sar245409 administration) and a follow-up visit (within 30 ± 3 days after the last sar245409 administration).

Eligibility criteria:
inclusion criteria : * solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival. * male or female patient \> or = 18 years old. * eastern cooperative oncology group performance status \< or = 1. * adequate white blood cells, platelets and haemoglobin. * adequate liver and kidney functions. * fasting plasma glucose \< 160 mg/dl. * no other malignancy. * women of childbearing potential using adequate contraception. exclusion criteria: * history of partial or full gastrectomy. * lymphoma involving the gastrointestinal tract. * uncontrolled brain metastases or a primary brain tumor. * prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin c within 6 weeks, before the first dose of study treatment. * prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study treatment. * any other investigational therapy within 4 weeks before the first dose of study treatment. * prior anticancer hormonal therapy within 1 week before the first dose of study treatment. * prior radiation therapy within 2 weeks before the first dose of study treatment. * intolerance of prior treatment with a pi3k inhibitor. * hereditary or acquired immunodeficiency syndrome or hiv (human immunodeficiency virus) infection. * lymphoma patients with positive serologies for hepatitis b surface antigen (hbsag) or anti-hepatitis c virus (anti-hcv) antibodies. * positive serologies for hepatitis b surface antigen (hbsag) or anti-hepatitis c virus (anti-hcv) antibodies. * patient is pregnant or breastfeeding. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.